510(k) · Cleared
ClearedSite-Rite 3 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dymax Corp · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 10, 1999 as substantially equivalent to K862127 (Dymax Corp, 1986) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1985. 2 of the 278 devices in its family, counting itself, have a Class I recall. 275 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850478 (1985). 2 ancestors in all. 275 later devices descend from it, 5 citing it directly. 2 of the 278 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK850478 PLUS 1Dymax Corp · 1985
- This deviceK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- Descendant · cites it directly · 140 of its ownK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- Descendant · 2 generations on · 139 of its ownK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- Descendant · 3 generations on · 136 of its ownK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- Descendant · cites it directly · 124 of its ownK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
- Descendant · 2 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
Showing 5 of 275 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 275 · See all- K032135Site-Rite IV Ultrasound SystemDymax Corp · 2003 · cites it directly140descendants
- K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005 · 2 generations on139descendants
- K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007 · 3 generations on136descendants
- K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002 · cites it directly124descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| 0 (this device) | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| +1 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| +2 | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| +3 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| +1 | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | Sonosite,Inc. | 2002 | — |
| +2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 12 | 0 |
| 2020 | 27 | 0 |
| 2021 | 23 | 0 |
| 2022 | 24 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 30 | 2 |
| 2026 | 26 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862127 | Dymax Personal ScannerSummary page 1…LY MARKETED PREDICATE DEVICES The Site~Rite 3 Ultrasound Scanner is substantially equivalent to the Site~Rite 2 Ultrasound Scanner (cleared as the Dymax Plus 1 Scanner, K862127) and the Dymax Plus 1 (cleared as the Dymax TM18, K850478). B. DEVICE DESCRIPTION The Site-Rite 3 pulsed echo ultrasound system… | 1986 |
| * | K850478 | PLUS 1Summary page 1…Scanner is substantially equivalent to the Site~Rite 2 Ultrasound Scanner (cleared as the Dymax Plus 1 Scanner, K862127) and the Dymax Plus 1 (cleared as the Dymax TM18, K850478). B. DEVICE DESCRIPTION The Site-Rite 3 pulsed echo ultrasound system is a lightweight, low- output, portable, real-time, B-mod… | 1985 |
What descends from it? (275)
See all 2755 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032135 | Site-Rite IV Ultrasound System | 2003 | 140 |
| K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | 2002 | 124 |
| K030191 | Terason Model 2000/Bas Portable Ultrasound System | 2003 | 24 |
| K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… | 2003 | 13 |
| K021984 | Punctsure Ultrasound Vascular Imaging System; Puncturesure Vascular Imaging Procedure Kit | 2002 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Site~Rite 3 ultrasound system with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.
The Site~Rite 3 is not intended for opthalmic applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993624: Site-Rite 3 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993624
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026